June 8, 2016
John Mackey, Co-Chief Executive Officer
Walter Robb, Co-Chief Executive Officer
Whole Foods Markets Inc.
550 Bowie Street
Austin, TX 78703
Dear Mr. Mackey & Mr. Robb:
The U.S. Food and Drug Administration (FDA) inspected your multiple food manufacturing facility, Whole Foods Market North Atlantic Kitchen, 9 Commercial St, Suite 300, Everett, MA 02149-5506, on February 10, 11, 16, 18, & 26, 2016. The inspection found serious violations of the FDA’s Current Good Manufacturing Practice (cGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the food products manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code(U.S.C.) § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page at www.fda.gov.
The serious cGMP violations noted during the inspection were outlined on a Form FDA-483, Inspectional Observations, issued to Mr. Brian Corbley, Facility Team Leader at the close of the inspection. A copy is enclosed for your review. Those violations include the following:
1. Your firm failed to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination as required by 21 CFR 110.80(b)(2). Specifically, we observed:
- On February 10, 2016, you were mixing ready to eat pesto pasta directly under an area in the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
- On February 16, 2016, you were storing an uncovered rack of ready to eat mushroom quesadilla in the same area of the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
- On February 10, 2016, your employee transported uncovered ready to eat vegetables through a doorway, from the Veg Prep Room into the Prepared Veg Cooler. A significant amount of condensate had formed above the doorway and was dripping onto the surface below.
- On February 10, 2016, your employee was cutting chives and beets on a work surface directly underneath a leaking condensate drainage pipe in the Veg Prep Room.
- On February 16, 2016, you were holding uncovered ready to eat egg salad in large white barrels that were placed in an area below the condenser. Condensate was observed to be dripping at a rate of approximately once per second from the condenser fan bolts in the K8/K9 Room.
- On February 16, 2016, your employee transported uncovered ready to eat couscous through an area in the K8/K9 Room where condensate was dripping from an area around the condenser fan bolts at a rate of approximately once per second.
- On February 10, 16, & 18, 2016, you were holding ready to eat vegetables, utensils such as cutting boards, mandolins, stainless colanders and yellow plastic totes in close proximity to hand a washing station in the Veg Prep Room. The hand washing station does not have splash guards and is foot operated releasing water from the faucets with significant pressure causing water to splash outside the sink while employees were observed washing soiled hands. Water splashed onto covered and uncovered ready to eat vegetables, utensils and food containers.
- On February 16, 2016, your employee measured the strength of peracetic acid from the faucet in the Veg Prep Room with an (b)(4) Peracetic Acid test strip that indicated its strength over 160 ppm (maximum level on the test strip). This concentration exceeds the maximum level recommended by the (b)(4) product information sheet and the maximum level allowed under 21 CFR Part 173.315(a) (5) for use of peracetic acid for surface treatment and soaking and rinsing of vegetables.
- On February 16, 2016, your employee was performing multiple tasks in the Pre-Pack Room including filling and weighing ready to eat egg salad in retail packs. The employee was observed cleaning and directly contacting work surfaces and then packaging and handling exposed product without hand washing or changing gloves in between tasks.
- On February 16, 2016, your employee in the Bulk-Pack Room was observed assembling bulk cartons while also packaging exposed ready to eat quinoa cakes without hand washing or changing gloves in between tasks.
- On February 16, 2016, your employee in the Pre-Pack Room was spraying (b)(4) quaternary ammonium based sanitizer to clean work surfaces while another employee in close proximity was packaging exposed ready to eat mesculin salad. This resulted in the sanitizer being sprayed onto an open colander of salad leafy greens.
- On February 16, 2016, your employee’s unprotected upper sleeves were frequently touching ready to eat leafy salad greens as leafy salad greens were packaged into retail packs in the Pre-Pack Room.
2. Your firm failed to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing as required by 21 CFR 110.80(b)(1). Specifically, on February 10, 2016 we collected an environmental sample (INV 911932), which consisted of one hundred (100) swabs/subs, from food contact and non-food contact surfaces throughout your manufacturing facility. FDA laboratory analysis of these subs confirmed the presence of non-pathogenic bacteria Listeria welshimeri in swab #39. Swab #39 was collected from the internal rotating drum portion, a food contact surface, of the (b)(4) vegetable chopping machine located in the Veg Prep Room. The presence of Listeria spp., such as the non-pathogenic Listeria welshimeri, detected on a food contact surface in your manufacturing facility is specifically used as an indicator for the probable presence of Listeria monocytogenes in your processing environment. This finding demonstrates that conditions exist in and on your equipment that would support the presence and growth of Listeria monocytogenes and indicates that your cleaning and sanitation practices may not be adequate. Your firm should consider improving your environmental monitoring program to verify the adequacy of your cleaning and sanitation operation.
3. Your firm failed to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned as required by21 CFR 110.35(d)(1). Specifically,
- On February 16, 2016, you filled the dip tank for soaking sheet pans (used for raw meats and ready to eat in process and finished products) with a quaternary ammonium based sanitizing agent. You measured the sanitizer strength using a color based test strip which indicated the sanitizer strength at 100ppm. This strength is not adequate for sanitizing foodcontact surfaces and the manufacturer recommended limit of the sanitizing product you were using was identified as 200-400ppm.
- On February 16, 2016, you measured the sanitizer strength on the spray nozzle located in the dish washing room that is used for filling the dip tank and for sanitizing larger portable equipment such as the rotating blades of (b)(4) machine and Ribbon Blender parts. The color based test strip indicated the sanitizer strength to be 100ppm. This strength is not adequate for sanitizing foodcontact surfaces and the manufacturer recommended limit of the sanitizing product you were using was identified as 200-400ppm.
- On February 16, 2016, you did not clean and sanitize the semi-permanent divider curtain in the K8/K9 Room after using a high pressure spray hose to clean and sanitize the ribbon blender and the walls and floors surrounding the ribbon blender.
- On February 10, 2016, you were storing various utensils and equipment parts inside containers and on rolling carts that had pooling water in or on them.
4. Your firm failed to take proper precautions to protect food and food-contact surfaces from contamination with chemicals, filth and extraneous materials due to deficiencies in plant design as required by21 CFR 110.20(b)(2). Specifically, we observed:
- You failed to keep soiled dishes separate from ready to eat products and you are using portable divider curtains and semi-permanent divider curtains to segregate areas between the dishwashing room entrance/exit doors and the Assembly Room where ready to eat products are assembled. Soiled and insanitary equipment from various preparation processes including holding of raw chicken and turkey were observed touching both sides of the portable divider curtains.
- On February 10 & 16, 2016, your employees in the K8/K9 Room used high pressure hoses to clean the ribbon blender and the semi-permanent divider curtains, causing water and aerosolized spray from the cleaning activity to go beyond the portable divider curtains and the semi-permanent divider curtains into areas where ready to eat food such as couscous and salad dressings were being prepared. The portable and semi- permanent divider curtains did not provide adequate protection of ready to eat food when high pressure hoses are used to clean and sanitize clean-in-place equipment and the portable and semi-permanent divider curtains.
- On February 10 & 16, 2016, soiled/unclean equipment , utensils and food containers had accumulated beyond the entrance of the dish washing room and portable divider curtains separating the dish washing room and the Assembly Area. This resulted in soiled/unclean equipment, utensils and food containers to be held for an indefinite period of time in close proximity to ready to eat manufacturing activities such as making of enchiladas, mixing of pesto pasta and quesadillas.
5. Your firm’s hand-washing facilities lack running water of a suitable temperature as required by 21 CFR 110.37(e). Specifically, on February 16, 2016 the hand washing station located at the entrance of the K8/K9 Room did not have warm/hot water. Your employees returning from break and other non-food related tasks continued to use this tagged “out of service, no hot water, 2/16/16” hand washing sink before returning to preparing and handling ready to eat foods.
6. Your firm failed to properly identify toxic sanitizing agents in a manner that protects against contamination of food as required by 21 CFR 110.35(b)(2). Specifically, we observed an unmarked drum of an unidentified chemical that was connected to the vegetable preparation sink in the Veg Prep Room. It was verbally identified as peracetic acid to be used to soak vegetables.
The above is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as injunction, or seizure.
Further, Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
We acknowledge receipt of your March 17, 2016 written response to the FDA Form-483 Inspectional Observations, issued to your firm on February 26, 2016. This response states that your firm takes these observations seriously and that your senior leadership is committed to take all the necessary measures to correct all the deficiencies. Despite this, FDA has serious concerns that our investigators found your firm operating under these conditions. Further, your response includes retraining of employees as a corrective action for most of the observed violations but you failed to mention adequate supervision over your specialized food processing operations and how retraining will ensure sustained compliance. We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented. This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections.
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or by email at email@example.com.
Joseph Matrisciano Jr.
New England District